How to meet the special design and quality needs of biopharm

1st April 2013

Regulations and time-to-market pressures leave little room for error in the biopharm market ­ but design quality, schedule and deliverables can all be enhanced using 3D technology, says Dean Martyniak.

The biotech/pharmaceutical (biopharm) industry faces its own unique set of challenges, such as time to market and compliance with industry regulations, along with the integration of buildings with process unit operations.

Especially challenging to the integrated design of process and building requirements is the incorporation of modular and skid design of process and process utility systems. As one of the top three pharmaceutical engineering companies (US), Foster Wheeler is well acquainted with the specific project needs and business drivers of the biopharm industry. The company performs 12 to 20 major (more than US$30 million) grassroots pharmaceutical projects per year worldwide, in addition to many smaller renovation and process upgrade projects.

The business drivers of the biopharm industry differ from those of the petrochemical and process industries. There are both business and project drivers that prioritise the execution of design in the biopharm industry.

The top biopharm industry business driver is time to market, or as it is more commonly described within the industry, aproduct to market'. This is because there is a finite patent life on pharmaceutical products, after which the introduction of generic equivalent products drastically reduces profitability. The spectre of the generic equivalent mandates that biopharm projects are very accelerated and fast-track.

The top project driver is to design and provide a facility that meets the stringent regulatory current good manufacturing practices (cGMP) guidelines. That means the processing operation must produce products that are manufactured under controlled conditions so that each and every product is consistent and meets specification ­ without exception. Project cost and facilities' cost are important in the context of keeping to a correct budget and supporting a very strict schedule.

Supporting the time to market requirement can be very challenging in the current busy construction climate, where labour is in high demand and productivity is low due to shortages of key resources.

The use of skidded systems and/or modules can benefit project execution by lowering the demand on skilled labour resources at the construction site and ensuring quality of the product by controlling the conditions under which the skids or modules are built. Both of these benefits can be key factors in reducing construction, validation and start-up schedule ­ to get the product to market as soon as possible.

The impact of 3D design technology

Foster Wheeler uses Intergraph Plant Design System (PDSTM) on most of its biopharm projects, and has found it to be a valuable asset. PDS provides an integrated set of design tasks that helps provide industry quality goals, a shorter schedule and deliverables for the construction process.

When used rigorously, it also provides an excellent platform for reviewing the design of a facility with both the client's engineering and operating personnel. This can help minimise late ­ and costly ­ changes in the project design cycle by providing visualisation of the design's physical details in the 3D model early in the design, where changes are less costly. As an aid to construction, this 3D modelling approach:

* Reduces interferences during construction.

* Clarifies subcontract scope and interdisciplinary relationships.

* Aids construction and planning.

* Provides data for progress and productivity tracking.

* Assists in the early procurement of materials.

Good communication between the engineer, client and constructor is always crucial. The engineer must be able to provide the constructors with a thoroughly reviewed design, and effectively communicate the facility design plans to them ­ otherwise, valuable time could be lost and costs could be increased due to holdups and rework.

The ability to review designs with the client community is of paramount importance. Many of Foster Wheeler's clients come from the research and development and manufacturing sides of the biopharm business, and may not be accustomed to reading design drawings.

The 3D aspects of PDS allow the clients to visualise what the actual plant looks like, and give them the opportunity to provide comments that will reflect operations, maintenance and safety needs that might not be obvious if presented with documents developed in a 2D design environment.

The data created in PDS can be reviewed and interrogated by the constructor and engineer in a Web environment. Additionally, use of the 3D plant environment and 3D database for collecting datasets associated with equipment and systems within the model creates the basis for an archival base system to support maintenance and future renovations.

These capabilities help Foster Wheeler to satisfy the project requirements of its biopharm clients ­ getting their facilities up and running in the shortest possible time, for the least cost and speeding their time to production. Versatility and ease of integration with other applications, from conceptual design to detailed design and construction is also key.

In the future, Foster Wheeler plans to expand its use of 3D modelling by focusing on the modular design of project elements for the more straightforward and repeatable aspects of design. Standard or base case configurations may be used over and over as the astarting' point to enhance efficiency and speed the design process along.

Dean Martyniak is senior vice-president for Foster Wheeler USA Corp. or





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